批准日期，申请提交历史，通知信，药品说明书，审评文件等信息
| 提交状态日期 | 提交号 | 审批结论 | 申请内容分类 | 审评优先级；罕用药状态 | 通知信、审评文件、说明书、包装标签 | 备注 |
|---|
| 2020/07/16 |
SUPPL-2（补充） |
Approval |
Labeling |
STANDARD
|
|
|
| 2020/06/25 |
SUPPL-1（补充） |
Approval |
Labeling |
STANDARD
|
|
|
| 2012/06/19 |
ORIG-1（原始申请） |
Approval |
Not Applicable |
|
|
|
与本品相关的专利信息（来自FDA橙皮书Orange Book）
| 关联产品号 | 专利号 | 专利过期日 | 是否物质专利 | 是否产品专利 | 专利用途代码 | 撤销请求 | 提交日期 | 专利下载 | 备注 |
|---|
| 无 |
与本品治疗等效的药品
活性成分:SUMATRIPTAN SUCCINATE 剂型/给药途径:TABLET;ORAL 规格:EQ 25MG BASE 治疗等效代码:AB
| 申请号 | 产品号 | 申请类型 | 商品名 | 活性成分 | 剂型/给药途径 | 规格 | 市场状态 | RLD | RS | TE Code | 产品号批准日期 | 申请人 |
|---|
| 020132 |
002 |
NDA |
IMITREX |
SUMATRIPTAN SUCCINATE |
TABLET;ORAL |
EQ 25MG BASE |
Prescription |
Yes |
No |
AB |
1995/06/01
|
GLAXOSMITHKLINE |
| 076554 |
001 |
ANDA |
SUMATRIPTAN SUCCINATE |
SUMATRIPTAN SUCCINATE |
TABLET;ORAL |
EQ 25MG BASE |
Discontinued |
No |
No |
AB |
2009/08/10
|
SUN PHARM INDS LTD |
| 076847 |
001 |
ANDA |
SUMATRIPTAN SUCCINATE |
SUMATRIPTAN SUCCINATE |
TABLET;ORAL |
EQ 25MG BASE |
Prescription |
No |
No |
AB |
2009/08/10
|
DR REDDYS LABS INC |
| 076933 |
001 |
ANDA |
SUMATRIPTAN SUCCINATE |
SUMATRIPTAN SUCCINATE |
TABLET;ORAL |
EQ 25MG BASE |
Prescription |
No |
No |
AB |
2009/08/10
|
WATSON LABS |
| 077744 |
001 |
ANDA |
SUMATRIPTAN SUCCINATE |
SUMATRIPTAN SUCCINATE |
TABLET;ORAL |
EQ 25MG BASE |
Prescription |
No |
No |
AB |
2009/08/10
|
MYLAN |
| 078284 |
001 |
ANDA |
SUMATRIPTAN SUCCINATE |
SUMATRIPTAN SUCCINATE |
TABLET;ORAL |
EQ 25MG BASE |
Prescription |
No |
No |
AB |
2009/08/10
|
ORBION PHARMS |
| 078295 |
001 |
ANDA |
SUMATRIPTAN SUCCINATE |
SUMATRIPTAN SUCCINATE |
TABLET;ORAL |
EQ 25MG BASE |
Prescription |
No |
No |
AB |
2009/08/10
|
SUN PHARM INDS |
| 078327 |
001 |
ANDA |
SUMATRIPTAN SUCCINATE |
SUMATRIPTAN SUCCINATE |
TABLET;ORAL |
EQ 25MG BASE |
Prescription |
No |
No |
AB |
2009/08/10
|
AUROBINDO PHARMA |
| 200263 |
001 |
ANDA |
SUMATRIPTAN SUCCINATE |
SUMATRIPTAN SUCCINATE |
TABLET;ORAL |
EQ 25MG BASE |
Prescription |
No |
No |
AB |
2012/06/19
|
COREPHARMA |
活性成分:SUMATRIPTAN SUCCINATE 剂型/给药途径:TABLET;ORAL 规格:EQ 50MG BASE 治疗等效代码:AB
| 申请号 | 产品号 | 申请类型 | 商品名 | 活性成分 | 剂型/给药途径 | 规格 | 市场状态 | RLD | RS | TE Code | 产品号批准日期 | 申请人 |
|---|
| 020132 |
003 |
NDA |
IMITREX |
SUMATRIPTAN SUCCINATE |
TABLET;ORAL |
EQ 50MG BASE |
Prescription |
Yes |
No |
AB |
1995/06/01
|
GLAXOSMITHKLINE |
| 076554 |
002 |
ANDA |
SUMATRIPTAN SUCCINATE |
SUMATRIPTAN SUCCINATE |
TABLET;ORAL |
EQ 50MG BASE |
Discontinued |
No |
No |
AB |
2009/08/10
|
SUN PHARM INDS LTD |
| 076847 |
002 |
ANDA |
SUMATRIPTAN SUCCINATE |
SUMATRIPTAN SUCCINATE |
TABLET;ORAL |
EQ 50MG BASE |
Prescription |
No |
No |
AB |
2009/08/10
|
DR REDDYS LABS INC |
| 076933 |
002 |
ANDA |
SUMATRIPTAN SUCCINATE |
SUMATRIPTAN SUCCINATE |
TABLET;ORAL |
EQ 50MG BASE |
Prescription |
No |
No |
AB |
2009/08/10
|
WATSON LABS |
| 077744 |
002 |
ANDA |
SUMATRIPTAN SUCCINATE |
SUMATRIPTAN SUCCINATE |
TABLET;ORAL |
EQ 50MG BASE |
Prescription |
No |
No |
AB |
2009/08/10
|
MYLAN |
| 078284 |
002 |
ANDA |
SUMATRIPTAN SUCCINATE |
SUMATRIPTAN SUCCINATE |
TABLET;ORAL |
EQ 50MG BASE |
Prescription |
No |
No |
AB |
2009/08/10
|
ORBION PHARMS |
| 078295 |
002 |
ANDA |
SUMATRIPTAN SUCCINATE |
SUMATRIPTAN SUCCINATE |
TABLET;ORAL |
EQ 50MG BASE |
Prescription |
No |
No |
AB |
2009/08/10
|
SUN PHARM INDS |
| 078327 |
002 |
ANDA |
SUMATRIPTAN SUCCINATE |
SUMATRIPTAN SUCCINATE |
TABLET;ORAL |
EQ 50MG BASE |
Prescription |
No |
No |
AB |
2009/08/10
|
AUROBINDO PHARMA |
| 200263 |
002 |
ANDA |
SUMATRIPTAN SUCCINATE |
SUMATRIPTAN SUCCINATE |
TABLET;ORAL |
EQ 50MG BASE |
Prescription |
No |
No |
AB |
2012/06/19
|
COREPHARMA |
活性成分:SUMATRIPTAN SUCCINATE 剂型/给药途径:TABLET;ORAL 规格:EQ 100MG BASE 治疗等效代码:AB
| 申请号 | 产品号 | 申请类型 | 商品名 | 活性成分 | 剂型/给药途径 | 规格 | 市场状态 | RLD | RS | TE Code | 产品号批准日期 | 申请人 |
|---|
| 020132 |
001 |
NDA |
IMITREX |
SUMATRIPTAN SUCCINATE |
TABLET;ORAL |
EQ 100MG BASE |
Prescription |
Yes |
Yes |
AB |
1995/06/01
|
GLAXOSMITHKLINE |
| 076572 |
001 |
ANDA |
SUMATRIPTAN SUCCINATE |
SUMATRIPTAN SUCCINATE |
TABLET;ORAL |
EQ 100MG BASE |
Discontinued |
No |
No |
AB |
2009/02/09
|
SUN PHARM INDS LTD |
| 076847 |
003 |
ANDA |
SUMATRIPTAN SUCCINATE |
SUMATRIPTAN SUCCINATE |
TABLET;ORAL |
EQ 100MG BASE |
Prescription |
No |
No |
AB |
2009/08/10
|
DR REDDYS LABS INC |
| 076933 |
003 |
ANDA |
SUMATRIPTAN SUCCINATE |
SUMATRIPTAN SUCCINATE |
TABLET;ORAL |
EQ 100MG BASE |
Prescription |
No |
No |
AB |
2009/08/10
|
WATSON LABS |
| 077744 |
003 |
ANDA |
SUMATRIPTAN SUCCINATE |
SUMATRIPTAN SUCCINATE |
TABLET;ORAL |
EQ 100MG BASE |
Prescription |
No |
No |
AB |
2009/08/10
|
MYLAN |
| 078284 |
003 |
ANDA |
SUMATRIPTAN SUCCINATE |
SUMATRIPTAN SUCCINATE |
TABLET;ORAL |
EQ 100MG BASE |
Prescription |
No |
No |
AB |
2009/08/10
|
ORBION PHARMS |
| 078295 |
003 |
ANDA |
SUMATRIPTAN SUCCINATE |
SUMATRIPTAN SUCCINATE |
TABLET;ORAL |
EQ 100MG BASE |
Prescription |
No |
No |
AB |
2009/08/10
|
SUN PHARM INDS |
| 078327 |
003 |
ANDA |
SUMATRIPTAN SUCCINATE |
SUMATRIPTAN SUCCINATE |
TABLET;ORAL |
EQ 100MG BASE |
Prescription |
No |
No |
AB |
2009/08/10
|
AUROBINDO PHARMA |
| 200263 |
003 |
ANDA |
SUMATRIPTAN SUCCINATE |
SUMATRIPTAN SUCCINATE |
TABLET;ORAL |
EQ 100MG BASE |
Prescription |
No |
No |
AB |
2012/06/19
|
COREPHARMA |